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Description
Carbocisteine is a mucus thinner that mainly affects the secretion of bronchial glands at the cellular level, which is beneficial for the removal of sputum. Our carbocisteine API has low impurities and can be directly used to make carbocisteine finished drugs. Its quality has been recognized by many domestic and foreign pharmaceutical companies, and we have obtained the WC certificate for API export to the EU.
Details
Specification
Carbocisteine | EP11 | CP2020 | BP2024 |
Assay | 98.5%~101.0% | ≥98.5% | 98.5%~101.0% |
pH | 2.8~3.0 | 2.8~3.0 | 2.8~3.0 |
Specific optical rotation[a]D20° | -32.5°~ -35.5° | -32.5°~ -36.0° | -32.5°~ -35.5° |
State of solution | Clear and colorless | Clear and colorless | Clear and colorless |
Transmittance(T430) | / | ≥95.0% | |
Chloride | ≤0.15% | ≤0.15% | ≤0.15% |
Cysteine | / | ≤0.05% | |
Other amino acids | / | ≤0.5% | |
Sulfate (SO4) | ≤300ppm | / | ≤300ppm |
Iron(Fe) | / | ≤0.001% | |
Heavy metals(Pb) | / | ≤20ppm | |
Loss on drying | ≤0.50% | ≤0.50% | ≤0.50% |
Sulphated ash | ≤0.30% | ≤0.20% | ≤0.30% |
Ninhydrin-positive substances | ≤0.50% | / | ≤0.50% |
Total plate count | ≤1000cfu/g | ≤1000cfu/g | ≤1000cfu/g |
Yeast and Mold | ≤100 cfu/g | ≤100 cfu/g | ≤100 cfu/g |
Related compound I | / | ≤0.10% | |
Related compound II | / | Total impurities<0.5% | |
Total related compound | / | ≤1.0% | |
Chloroacetic acid | / | ≤0.05% |